Faus Moliner participates at the Course on Pharmaceutical Law organized by CEFI

In recent years, the Course on Pharmaceutical Law organized by the CEFI Foundation has established itself as a reference forum for the legal analysis of the various issues that arise during the life of a drug.

In this latest edition, held in Madrid on 05 and 06 March 2024, Faus Moliner has participated with three presentations.

Lluís Alcover presented a paper on the challenges and opportunities of health technology assessment in Spain. In a debate in which the Director General for the Common Portfolio of NHS Services and Pharmacy, César Hernández, also participated, Lluís stated that “the new Royal Decree on health technology assessment should contemplate a broad social perspective, reflecting the total value of the drug for the NHS, but also for patients and society as a whole”.

Joan Carles Bailach, for his part, made a presentation on the application of the Transparency Law in the drug sector now that 10 years have passed since its approval. Joan Carles Bailach argued that the debate on the confidentiality of the price and financing conditions of medicines in Spain is a hot topic. In this regard, Joan Carles Bailach stated that “while the jurisprudence and doctrine in other European countries seems to be oriented towards guaranteeing the confidentiality of the price and financing conditions, in Spain there is still no clear jurisprudence in this regard”. In this sense, he stated that it will be necessary to wait to see what the Supreme Court resolves on the merits of the issue.

Finally, Jordi Faus took part in the panel on the present and future of advanced therapies. During his presentation, Jordi Faus highlighted the most relevant aspects in relation to the reconfiguration of the hospital exemption in the framework of the review of the pharmaceutical legislation of the European Union, which seeks to bring together the currently divergent practices of the Member States. On this point, Jordi Faus recalled that the hospital exemption has always been configured as an exception to the general regime of the need for marketing authorization and stressed the need for this exceptionality to be maintained in the new European pharmaceutical legislation. All this so that there is no overlap with those advanced therapy drugs manufactured industrially, which are subject to a stricter regulatory regime.